Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

Persistent Atrial Fibrillation Clinical Trial

— LEAP-AF  

Official title:

Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405258
• Other study ID #: 947
• Status: Recruiting
• Phase: Phase 4
• Start date: June 8, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2023
• Source: Institute for Clinical Effectiveness, Japan
• Contact: Keisuke Okawa, MD
• Phone: +81-87-811-3333
• Email: k-ookawa[@]chp-kagawa.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).

Description:

PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for first catheter ablation of persistent atrial fibrillation
• Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
• Patients with persisting duration of atrial fibrillation less than 3 years
• Patients with left atrial diameter less than 50mm
• Patients who can be followed up for 18 months
• Patients with written informed consent

Exclusion Criteria:

• Patients who can not be received adequate anticoagulation therapy
• Patients with history of myocardial infarction within 6 months
• Patients with history of open heart surgery
• Patients scheduled for open heart surgery
• Patients with severe valvular heart disease
• Patients during pregnancy
• Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
• Patients considered unsuitable for study by the attending physician

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation
• Persistent Atrial Fibrillation
• Posterior Wall Isolation
• Pulmonary Vein Isolation

Intervention

Procedure:
• Pulmonary vein isolation
Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
• Left posterior wall isolation
Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation

Locations

Country	Name	City	State
Japan	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation	Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.	18 months
Secondary	Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation	Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.	18 months
Secondary	Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation	Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.	90 days
Secondary	Repeated ablation of atrial tachyarrhythmia		18 months
Secondary	Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation		18 months
Secondary	Atrial Fibrillation Quality of Life Questionnaire	Atrial Fibrillation Quality of Life Questionnaire	18 months
Secondary	Complications of ablation procedure	Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury	1 month